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Diclofenac sachet composition

a technology of diclofenac and sachet, which is applied in the direction of powder delivery, pharmaceutical delivery mechanism, organic active ingredients, etc., can solve the problems of diclofenac sachet, sachets are more difficult to dissolve, and the hurdles are magnified

Pending Publication Date: 2022-08-04
PATRIN PHARMA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention is about a method for treating migraines and preventing their symptoms, including pain, photophobia, phonophobia, and nausea. The method involves quickly absorbing a compound called diclofenac into the body, which can be done through oral administration. This compound helps to reduce the severity and duration of migraines and associated symptoms. The invention also provides a formulation of diclofenac that is consistent and easily absorbed by the body.

Problems solved by technology

One of the primary obstacles in the manufacture of powder sachets is the distribution of the drug in the powder, and the uniformity of content in the finished product.
These hurdles are magnified in the production of diclofenac sachets due to the poor aftertaste of diclofenac and the need to incorporate additional ingredients to compensate for this poor taste.
The method described in the Reiner et al. patent filing produces an excellent pharmaceutical dosage form, but suffers from a number of disadvantages including the size of the sachet (2 g) which makes the sachet more difficult to dissolve, and the presence of sugar in the formulation, which should be avoided in the diabetic population.

Method used

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  • Diclofenac sachet composition

Examples

Experimental program
Comparison scheme
Effect test

example 1

ative 900 mg—Powder Sachet Formulation

[0099]Table 2 describes the composition of a representative 900 mg powder sachet formulation containing 50 g of diclofenac potassium that is suitable for practicing the present invention.

TABLE 2Quantity / PacketSr. No.Name of the ingredient(in mg)in % w / w1.Mannitol (Mannogem ®721.0081.38Granular)2.Diclofenac Potassium50.005.643.Polyethylene Glycol8.000.908000 (Carbowax SentryPEG 8000)4.Methanolqsqs5.Purified Waterqsqs6.Star Anise Flavour SD15.001.697.Sucralose55.006.218.Peppermint Flavour35.003.959.Glyceryl Dibehenate2.000.23Final Weight886.00100.00

[0100]The FIGURE is a flow diagram illustrating a wet granulation method and sequence of mixing employed in making 900 mg powder sachets of the invention that contain 50 mg of diclofenac potassium.

example 2

ring Process for 900 mg Powder Sachets Containing 50 mg of Diclofenac Potassium

[0101]A representative process for manufacturing 900 mg powder sachets containing 50 mg of diclofenac potassium is set forth below, using the equipment set forth in Table 3 below. The manufacture is performed under controlled temperature and relative humidity according to the following process.

TABLE 3Step Description1Dispensing: Dispense all the ingredients as per formula sheet.2Drug-Binder Dispersion Preparation:2.1 Solvent System Preparation: Dispense 2.508 kg of Methanol and 0.358 kg of Purified water and mix together to obtain uniform solvent system. Additionally, dispense 0.230 kg of Methanol (i.e. 0.55% w / w of Mannogem ®Granular) for rinsing purpose.2.2 Drug-Binder Dispersion Preparation: Add 0.464 kg of Polyethylene Glycol 8000 to the solvent system of step 2.1 and stir to obtain clear solution. Then add 2.901 kg of Diclofenac Potassium to the obtained clear solution under constant mechanical stirr...

example 3

n of Different Grade of Diluent Mannitol

[0102]In this study, another grade of Mannitol was evaluated. The average particle size of Pearlitol 400 DC is 360μ. Another grade of Mannitol i.e., Mannogem® Granular (Source: SPI Pharma) with average particle size of −400 microns was chosen. The manufacturing process executed was same as described for the previous batch i.e., wet granulation approach with drug and binder solution mixture.

[0103]The composition of the formulation, brief manufacturing process and comparative analysis is set forth in Table 4 below.

TABLE 4Unit Composition50 mgBatch Nos.IQ014(010)19 & IQ014(010)21Sr. No.IngredientsMg / SachetIntragranular1Mannitol 721.00(Mannogem ®Granular)2Sucralose 55.00(Sucrex)Binder Solution3Diclofenac 50.00Potassium*4Polyethylene 8.00Glycol 8000 (Carbowax SentryPEG 8000)5MethanolQS6Purified QSWaterExtragranular7Star Anise 15.00Flavour SD (0499085)**8Peppermint 35.00Flavour (PL-0132)9Glyceryl 2.00DibehenateTotal Weight886.00*Actual quantity of A...

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Abstract

A pharmaceutical composition for oral administration comprising a free-flowing granular powder comprising diclofenac or a pharmaceutically acceptable salt thereof, a pharmaceutically acceptable substantially non-hygroscopic water soluble diluent, an optional binder, and one or more optional pharmaceutically acceptable excipients, wherein the composition is devoid of any alkalizer, buffer or base. The pharmaceutical composition is divided into unit doses containing a therapeutically effective amount of diclofenac, and may be incorporated into sachets, tablets or capsules. and not less than 85% of the free-flowing granulate powder dissolves after 3 minutes in simulated intestinal fluid at pH 6.8. The pharmaceutical composition is rapidly bioavailable when orally administered to a mammal, e.g., human.

Description

FIELD OF THE INVENTION[0001]The present invention provides a pharmaceutical composition for treating migraine and other acute pain episodes in a mammal (e.g. human) which includes diclofenac or pharmaceutically acceptable salt thereof in poser sachets. The invention further concerns methods and formulations for treating symptoms that often accompany migraine and acute pain such as rebound headache, photophobia, phonophobia, nausea and vomiting.BACKGROUND OF THE INVENTION[0002]Diclofenac is a non-steroidal anti-inflammatory drug (“NSAID”) known chemically as [(2,6-dichloro-anilino)-2-phenyl]-2-acetic acid.[0003]Diclofenac is widely used for treating various types of pain, including both chronic and acute painful episodes. The drug is administered for the treatment of musculoskeletal and joint disorders such as rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis; periarticular disorders such as bursitis and tendonitis; soft tissue disorders such as sprains and strains, an...

Claims

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Application Information

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IPC IPC(8): A61K31/196A61K9/00A61K9/16
CPCA61K31/196A61K9/0053A61K9/009A61K9/1641A61K9/1623
Inventor TRIVEDI, JAY SANJAYKODGULE, MANDAR MADHUKARDARANDALE, SHARAD SHRIDHARELLA, RASHMITA DURYODHAN
Owner PATRIN PHARMA INC